Quality Control Metrologist

Job Description Summary

In this individual contributor role, the Metrologist is responsible for a variety of tasks related to calibrations of equipment, managing, and overlooking equipment change requests in a timely manner. Contacts vendors, when needed, and coordinates their activities.

Novartis is unable to offer relocation support for this role. Please only apply if the location is accessible for you.

Location : Millburn, NJ #LI-Onsite

Job Description

Key Responsibilities :

• Responsible for effective and efficient calibration to ensure compliance with Novartis quality standards and applicable CGMP regulations.

Facilitates instrumentation calibration / qualification with external vendors, internal and / or external resources and local system owners.

Supports the preparation of equipment binders containing technical & qualification Novartis life cycle documents & required vendor documents, IQ / OQ / PQ Protocols, and Summary Reports for qualification of QC equipment.

Ensure compliance with cGMP, regulatory regulations, and Novartis global and local policy for equipment.

Develop / review appropriate SOPs and corresponding Forms.

Responsible for performing all assigned activities within budget and schedule constraints.

Ensure communication flows within the team and with all individual involved in the process (e.g. Make- Test- Release team).

As subject matter expert provide support during audit and inspection.

Responsible for performing all assigned activities within budget and schedule constraints

Essential Requirements :

Bachelor's degree in science or related field with 3+ years of experience in pharmaceutical industry or High School Diploma with 7 years of experience in pharmaceutical industry

3+ years of pharmaceutical industry experience required.

Minimum of 2 years of laboratory instrument calibration, preventative maintenance experience, or applicable experience in a related area

Working knowledge of aseptic manufacturing, cGMPs, GLPs and applicable compendial and regulatory guidelines (e.g. FDA, EP, JP)

Experience with LIMS and BMRAM preferred

Strong written and verbal communication skills.

Detail-oriented with expertise in problem solving and solid decision-making abilities.

Strong interpersonal skills.

Novartis Compensation and Benefit Summary : The salary for this position is expected to range between $77,400 and $143,000 / year. The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors. Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

EEO Statement :

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$77,000.00 - $143,000.00

Skills Desired

Agility, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise